HIATAL HERNIA DEFECTS AND THE USES OF MESH VERSUS HUMAN GRAFTS

The purpose of this Medical Research Review is to present results of current studies evaluating the postoperative results of Hiatal Hernia defects, with special emphasis on the recurrence rate and reflux after surgery comparing the use or not of mesh reinforcement.

Hiatal Hernia is a structural defect in which a weakened diaphragm allows a portion of the stomach to pass through the esophageal diaphragmatic opening (hiatus) into the chest when intra-abdominal pressure increases. (1) Normally, the esophagus or food tube passes down through the chest, crosses the diaphragm, and enters the abdomen through a hole in the diaphragm called the esophageal hiatus. Just below the diaphragm, the esophagus joins the stomach. In individuals with hiatal hernias, the opening of the esophageal hiatus (hiatal opening) is larger than normal, and a portion of the upper stomach slips up or passes (herniates) through the hiatus and into the chest. (3) Three types of hiatal hernia occur: sliding hernia (most common), paraesophageal (rolling) hernia, or mixed hernia, which includes features of both of the other two. In a sliding hernia, both the stomach and the gastroesophageal junction slip up into the chest so that the gastroesophageal junction is above the diaphragm. In a paraesophageal hernia, a part of the greater curvature of the stomach rolls through the diaphragm. (1) (Photos for examples can be provided). (1, 3)

Causes of Hiatal Hernia can be due to muscle weakening of the diaphragm associated with: aging, esophageal carcinoma (cancer of the esophagus), kyphoscoliosis (a lateral curvature of the spine), trauma, certain surgical procedures, congenital (present at birth) diaphragmatic malformations, or intra-abdominal pressure. (1)

In a sliding Hiatal Hernia, symptoms occur in the presence of an incompetent gastroesophageal sphincter (a circular muscle constricting the opening into the stomach). A patient may exhibit such symptoms such as pyrosis (heartburn), occurring 1 to 4 hours after eating and aggravated by increased intra-abdominal pressure, accompanied by regurgitation or vomiting or retrosternal (behind the sternum, the bone lying mid chest) or substernal (under the sternum) chest pain. This chest pain often occurs after meals or at bedtime and is aggravated by reclining, belching, and increased intra-abdominal pressure. In a Paraesophageal hiatal hernia, the patient is typically asymptomatic, although the hernia rarely causes the symptoms, it may be an anatomic component of gastroesophageal reflux disease (GERD). With GERD, the patient may have a feeling of fullness in the chest or pain resembling angina (chest pain). (1)

Treatment includes therapy which attempts to modify or reduce the reflux by decreasing or changing the amount or quality of the stomach contents, by strengthening the gastroesophageal sphincter muscle using medications, or by decreasing the amount of reflux of the stomach juices through gravity, such as instructing the patient to sit up after meals. Antacids modify the fluid refluxed into the esophagus and are probably the best treatment for intermittent reflux. Medications called Histamine 2 blockers, such as Famotidine (Mylanta-AR, Pepcid, Pepcid AC, Pepcidine), also can decrease the fluid refluxed into the esophagus. Drug therapy to strengthen gastroesophageal sphincter tone may include cholinergic agents such as bethanechol (Duvoid, Myotonachol, Urabeth, Ulrocarb). Failure to control symptoms by medical means or onset of complications require surgical repair. A paraesophageal hiatal hernia, even one that causes no symptoms, needs surgical treatment because of the high risk of strangulation. (1) Techniques vary greatly but most create an artificial closing mechanism (hiatoplasty) at the junction of the esophagus and the stomach to strengthen the lower esophagus sphincter function. (1) A Nissen Fundoplication is a surgical procedure to treat gastroesophageal reflux (GERD) and hiatus hernia. Dr. Rudolph Nissen first performed the procedure in 1955. In a fundoplicaton, the gastric fundus (upper part) of the stomach is wrapped around the lower end of the esophagus and stitched into place, reinforcing the closing function of the lower esophageal sphincter. The esophageal hiatus is also narrowed down by sutures to prevent or treat concurrent hiatal hernia. (5) Laparoscopic (Abdominal exploration employing a type of endoscope called a laprascope) anti-reflux surgery, often called LARS, has been popular since 1991 as the approach for hernia repair. (4, 6) The laparoscopic repair of large hiatal hernia followed by an antireflux procedure is currently the gold standard therapy for gastroesophageal reflux disease. (9, 16) Crural Closure technique for closure of herniation is utilized, and is obtained with simple surgical closure of the two halves of the right crus, closed anterior to the esophagus. (8) Laparoscopic repair of a hiatal hernia has been associated with high recurrence rate of reflux. (5, 17, 18) It has been recognized that failure of hiatal hernia closure, recurrent hiatal herniation and wrap migration are major sources of operative failures in these patients. (9, 11, 12, 14, 15, 16) The use of biologic or synthetic mesh to reinforce the herniation repair has been shown to reduce recurrence. (6, 9, 10, 11, 12, 13, 14, 15, 16, 17)

In a study conducted by Braghetto (2010), emphasis was on the recurrence rate and reflux after surgery comparing the use or not of mesh reinforcement. This prospective study included 81 patients with a complete evaluation through a clinical questionnaire, barium sulfate radiologic evaluation, endoscopy, manometry, and 24-hour intraesophageal pH monitoring before and after a hiatoplasy with an antireflux procedure. Mesh reinforcement was used in 23 patients. Post operative complications occurred in 11 patients (13.6%), without mortality. Recurrent hernia was observed in 10 patients without mesh reinforcement (12.3%), whereas those with mesh reinforcement showed no hiatal hernia recurrence (P=0.33). The study concluded that mesh reinforcement could prevent recurrent hiatal hernias. (6)

In a study by Soricelli (2009), evaluation was made of the long –term results of LARS with or without the use of Mesh in patients treated from 1992 to 2007. Crural closure was performed by means of two or three interrupted nonabsorbable sutures for 93 patients (group A), by tailored 3 x4 cm polypropylene mesh placement for 113 patients (group B), and by nonabsorbable suture plus superimposed tailored mesh for 91 patients (group C). Intrathoracic Nissen wrap migration or hiatal hernia recurrence occurred for nine patients (9.6%) in group A, two patients (1.8%) in group B, and only one patient (1/1%) in group C. Esophageal erosion occurred in only one case (0.49%). This study concluded that long-term use of a prosthetic mesh in the crura for hiatal hernia repair proved to be effective in reducing the rate of postoperative intrathoracic wrap mitigation or hernia recurrence, with a very low incidence of mesh-related complications(9)

In a study conducted by Hazebroek (2009), 19 patients underwent laparoscopic hiatal hernia repair with DualMesh reinforcement of the crural closure. Quality of life and symptom analysis was performed using quality of life in reflux and dyspepsis (QOLRAD) questionnaires pre- and post operatively after 6 weeks, 6 months, 1 year and 2 years. Barium studies were performed on patients pre-operatively and two years postoperatively to assess hernia recurrence. After 2 years, oesophagogastric endoscopy was performed to assess signs of erosion. Follow-up barium studies performed at 31.3 months (range 29-40 months) after surgery showed moderate recurrent hernias (>4cm) in 1/14 patients (7%). Endoscopies performed at 34.3 months (range 28-41 months) after surgery did not show any signs of prosthetic erosion. There was no comparison group found in this study. (10)

In a retrospective study conducted by Zaninotto (2007), 54 patients with a diagnosis of large type III hiatal hernias underwent laparoscopic surgery from January 1992 to June 2005. Nineteen patients had laparoscopic Nissen/Toupet fundoplication with simple suture, and in 35 patients a double mesh was added. Recurrences occurred in 11/54 (20%) patients: 8/19 (42.1%) without mesh and 3/35 with mesh (p=0.01). Possible reasons for failure of a laparoscopic hiatal repair are tension or poor muscle tissue characteristics in the hiatus. (11)

In a study conducted by Jacobs (2007), 220 patients who underwent antireflux surgery with posterior cruroplasty between 1997 and 2005 were retrospectively reviewed. Patients were divided into 2 groups: posterior cruroplasty + absorbable mesh reinforcement (n=127) and posterior cruroplasty alone (n=93). Symptomatic outcome was assessed by telephone interview. In the mesh group, 74/92 (80%) patients remained asymptomatic at a median of 3.2 years postoperatively. These patients were tested with either an upper endoscopy or an upper gastrointestinal (UGI) series; none had recurrence of hiatal hernia. In the no mesh group, 26/59 (44%) patients were symptomatic. Of these, 18 underwent either an upper endoscopy or an UGI series. Recurrence of hernia was confirmed in 12 patients for a 20% overall proven recurrence rate. (12)

In a study conducted by Hazebroek (2008), data was collected on 18 patients undergoing laparoscopic repair of a large hiatal hernia with the use of TiMesh, a lightweight titanium-coated polypropylene mesh, between November 2004 and December 2005. Quality of life and symptom analysis was performed using QOLRAD questionnaires preoperatively and postoperatively after 6 weeks, 6 months, 1 year and 2 years. Barium studies were performed preoperatively and 2 years postoperatively to assess hernia recurrence. After 2 years, oesophagogastric endoscopy was performed to assess signs of mesh-related complications. Two years after hiatal hernia repair, there was significant improvement in quality-of-life scores (QOLRAD 5.79, p<0.001). No signs of stricture formation or prosthetic erosion were identified during endoscopic follow-up. (13)

In a study conducted by Granderath (2008), the purpose of the study was to evaluate the safety and effectiveness of circular hiatal onlay mesh prosthesis applied during laparoscopic refundoplication primary failed antireflux surgery with intrathoracic wrap migration. The follow up period was 5 years. A total of 33 patients with recurrent symptoms of reflux disease after failed laparoscopic or failed antireflux surgery underwent revisional surgery. The patients underwent a breakdown of the former fundoplication, revision of the esophageal hiatus with a polypropylene mesh used to buttress the sutured hiatal crura. All 33 patients were re-evaluated and underwent complete diagnostic work-up over a follow-up period of 60 months postoperatively. During the long-term follow-up, a new recurrent hiatal hernia with intrathoracic wrap migration developed in 2 patients (6%). In all other patients no recurrence occurred for the complete follow-up period, and no mesh related complications developed. (14)

In a study conducted by Champion (2003), 52 patients were studied using laparoscopic approach, crura suturing using permanent interrupted sutures and a prosthetic mesh was secured over the repair. A Nissen (42) or Tilley (9) fundoplication was performed in all but one patient. Postoperative gastroscopy or barium swallow had been performed on 27 patients with an average 25 month follow-up. There was one recurrence (1.9%) and no prosthetic erosion. (15)

In a study by Ringley (2006), 44 patients were enrolled in the study to compare hiatal closure with a biodegradable patch and simple suture curaplasty. Twenty two patients underwent large hiatal hernia repair (> 5 cm) and fundoplication with primary suture cruroplasty only (group 1) and were compared with 22 patients undergoing the same procedure with primary suture cruroplasty reinforced with an onlay patch. Patients in both groups were well matched by age, weight, height, and size of hiatal hernia. There were similar preoperative values in esophageal manometry, 24-hour pH monitoring, and symptom scoring in both groups. In group 1, 2 patients (9%) had Nissen failure with hiatal hernia recurrences 6 months after surgery. There were no recurrences for the follow-up period in group 2. (16)

In a study by Zehetner (2010), the study aimed to assess a simplified technique for reinforcing the crural repair using absorbable Vicryl mesh secured with BioGlue during laparoscopic repair of an intrathoracic stomach. Thirty five (35) patients underwent laparoscopic repair of an intrathoracic stomach from June 2006 to March 2009. Intrathoracic stomach was defined as more than 50% of the stomach herniated into the chest. Follow-up assessment was routinely performed 1 year or more after surgery and included endoscopy, video esophagram, pH monitoring and a gastroesophageal reflux (GERD) health-related quality-of-life (HRQL) questionnaire. There were three conversions (8.6% and one intraoperative complication (2.9%). No mesh related complications occurred. (17)

The last study for consideration was by Stadlhuber (2009), addressing Mesh complications as a 28-case series. This study compiled two cases and the senior author contacted other experienced esophageal surgeons (the number of which was not indicated) who provided 26 additional cases with mesh-related complications. Main reoperative findings were intraluminal mesh erosion (n=17), esophageal stenosis (n=6), and dense fibrosis (n=5). Six patients required esophagectomy, two patients had partial gastrectomy and 1 patient had total gastrectomy. The authors of this study concluded that complications related to synthetic mesh placement at the esophageal hiatus are more common than previously reported.

Conclusions from comparative research analysis included the following: The use of absorbable mesh is safe and may lead to a significant reduction in the incidence of symptomatic recurrent hiatal hernia. Laparoscopic reinforcement of primary hiatal closure with DualMesh leads to a durable repair in patients with large hiatal hernias. It is safe to proceed with lightweight titanium-coated polypropylene mesh (TiMesh) for reinforcement of the hiatal repair. Over a long-term follow-up period, the use of a prosthetic polypropylene mesh in the repair for hiatal hernia proved to be effective in reducing the rate of postoperative wrap migration or hernia recurrence, with a very low incidence of mesh-related complications. The use of mesh, either by reducing tension or reinforcing muscle at the hiatus, might be associated with a lower recurrence rate. The increase in postoperative dysphagia, chest pain, and esophageal erosions associated with nondegradable mesh has not been observed in those with patches used to this point. Vicryl mesh secured with BioGlue is a simple and easy method for reinforcing the crural closure during laparoscopic repair of an intrathoracic stomach. Recent publications of study results found in the literature regarding Mesh were felt to be favorable however several studies concluded however, for long-term follow-up, even with the placement of prosthetic mesh, re-recurrence occurs in some patients, leading to repeated surgery and that Long-term follow-up is required in all patients to determine the true incidence of anatomic recurrence and prosthetic erosion.